Status:
COMPLETED
A Comparison of Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries
Lead Sponsor:
Rothman Institute Orthopaedics
Conditions:
Joint Instability
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
I hypothesize that absorbable screw fixation of the foot's Lisfranc ligaments does not yield significant differences in postoperative foot stability, ligament function, and symptoms when compared to s...
Detailed Description
The Lisfranc ligaments are a group of ligaments that connect the bones of the middle portion of the foot to each other. The Lisfranc ligaments allow for a normal and stable range of motion and shape t...
Eligibility Criteria
Inclusion
- Subjects will be adults of any gender or race.
- Subjects will be adults between 18 and 75 years of age.
- The underlying diagnosis will be a Lisfranc foot injury.
- The indication for fixing the Lisfranc ligaments is abnormal separation of the middle part of the foot from each other.
- Subjects will have received either a steel or absorbable screw to fix the Lisfranc ligaments.
Exclusion
- Subjects may not have any cognitive impairment that would, in the investigator's opinion, preclude study participation or compliance with protocol mandated procedures.
- Subjects may not have a history of known alcohol, analgesic, or narcotic substance abuse within 12 months prior to pretreatment.
- Subjects may not have a history of severe psychiatric illness such as depression or psychosis that may influence the results of administered outcome questionnaires.
- Subjects may not be pregnant.
- Subjects may be excluded from this study for any reason that may pose unnecessary risk or confounding of data, in the judgment of the investigator. This includes the 4 above points.
- Subjects must not have intact or normal Lisfranc ligaments in the foot.
- Subjects may not have a history of deep Lisfranc joint infection.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00689962
Start Date
July 1 2008
End Date
July 1 2016
Last Update
January 18 2017
Active Locations (2)
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1
Riddle Memorial Hospital
Media, Pennsylvania, United States, 19063
2
Nazareth Hospital
Philadelphia, Pennsylvania, United States, 19152